Merck lobbyists work for papilloma virus (HPV) vaccine mandates:
Parental rights advocates say mandate premature
There is no dispute that vaccines have played a monumental role in promoting public health and safety for children and adults.
My concern has been that certain vaccines should not be forced fed or injected without more testing and information given to the public. The human papillomavirus (HPV) is one of these.
In decisive, bold, back-to-back news releases on Feb. 4, 2007, The Association of American Physicians and Surgeons voiced their concerns and issued an advisory statement.
Foreseen by parental rights advocates, the "recommendation" of human papillomavirus (HPV) vaccine (Gardasil) was immediately followed by legislative proposals to force 11-year-old girls to receive the vaccine as a condition of school attendance.
Merck, which could make $1 billion per year in sales from mandatory Gardasil, is funding lobbyists and funneling money through Women in Government, an advocacy group made up of female legislators. A top official from Merckıs vaccine division sits on the Women in Government business council. The company refused to disclose the amount of money it has donated to that group or spent on lobbying.
Laws are proposed in at least 18 states, including California, Connecticut, Michigan, Minnesota, and Texas. The bill was narrowly defeated in Michigan.
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Gov. Rick Perry decided to override the Texas legislature, issuing Executive Order RP65 requiring girls entering sixth grade, generally ages 11 to 12, to receive Gardasil.
The Executive Order stands until Perry or a successor changes it.
"He's circumventing the will of the people," said Dawn Richardson, president of Parents Requesting Open Vaccine Education. "There is no emergency except in the boardrooms of Merck, where this is failing to gain the support they expected."
A live vote by MSNBC News showed that 65 percent of those polled said "parents should decide whether or not their daughters are vaccinated." This was in response to the question "Should a state require that schoolgirls get the shot against human papillomavirus?"
There were more than 25,000 responses tallied.
Although there is a provision for parents to opt out for religious or philosophical reasons, parents complain that the Order interferes with their right to make medical decisions for their children, noted the Alliance for Human Research Protection.
Pediatricians and gynecologists have been refusing to stock Gardasil because of the $360 price for three doses and "totally inadequate insurance reimbursement."
According to the AP, most will give patients a prescription to get filled and bring back, but the cost to the patient is far more.
According to the National Vaccine Information Center, a survey of pediatric practices in Virginia revealed that parents could be charged between $525 and $930 for the series of shots.
According to the National Network for Immunization Information director, Martin Myers, "many of us are concerned that a mandate may be premature, and itıs important for people to realize that this is not as clear-cut as with some previous vaccines." Although Myers says heıs enthusiastic about Gardasil, "Itıs not the vaccine community that's pushing for this" (Immunization News, Feb. 1, 2007).
Gardasil is not approved for use in boys, so it cannot be marketed for this use, though physicians can prescribe it. It is hoped that Gardasil may prevent anal cancer in homosexual men.
In order to get a grasp on what the Association of American Physicians and Surgeons' concerns are, here is a summary of its statement:
The vaccine is claimed to prevent cancer of the cervix. Pap smears
have already made advanced cervical cancer rare in the United States. Money spent on this expensive vaccine could likely prevent more cancer if it were spent on screening clinics for women unable to afford vaccine, Pap smears, or treatment.
At best, the vaccine is only partly effective. No study has actually shown cancer prevention, only a reduction in abnormal Pap smears. The longest follow-up period in studies is about five years; it usually takes decades for cervical cancer to develop. The vaccine only protects against 70 percent of the strains associated with invasive cancers. Vaccinated women still need Pap smears.
Vaccine protection may only last a few years. Boosters may be needed every 10 years, or perhaps every five.
There is no public-health purpose for mandating HPV vaccine for
schoolchildren. It will not be transmitted at school unless statutory rape is occurring or hygienic standards are so poor that the school needs to be closed.
Safety is a concern, and so far proof of safety is lacking. The vaccine is claimed to be safe and "well-tolerated," but studies have involved only a few thousand women, most over 16 years of age, for less than 5 years. In one study, "arthritic symptoms" occurred three times as often in subjects who got the vaccine, compared to subjects who only got the control vaccine. An increased risk of juvenile rheumatoid arthritis, a deforming, devastating, lifelong disease, is being watched for.
Mandates are medically unethical. All medical procedures, including
vaccines, require informed consent, with rare exceptions. Concerning the HPV vaccine, the Department of Family Medicine and Clinical Epidemiology, University of Pittsburgh School of Medicine, concluded: "given concerns for autonomy, justice, as not all persons are at risk . . . HPV vaccine should not be mandated for school entry."
Until more testing and studies are performed, and the public has more knowledge of the safety and efficacy of the HPV vaccine, there is no need to rush to vaccination and certainly no need for mandatory inoculation.
Editor's Note; This week's fine column was written by Michael Arnold Glueck, M.D.
Michael Arnold Glueck, M.D., comments on medical-legal issues and is a visiting fellow in Economics and Citizenship at the International Trade Education Foundation of the Washington International Trade Council. Robert J. Cihak, M.D., is a senior fellow and board member of the Discovery Institute and a past president of the Association of American Physicians and Surgeons.